The Phase II clinical trial is an open-label, dose-escalating pharmacokinetic, pharmacodynamic, efficacy and safety study of CTA018 injection in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT) undergoing hemodialysis.
The Phase II study is being conducted in Canada and will enroll approximately 40 hemodialysis patients in a maximum of five dose groups. Each dose group will consist of eight subjects treated for four weeks. Efficacy will be evaluated by the proportion of subjects who achieve at least a 30% reduction in intact parathyroid hormone (iPTH) from pre-treatment baseline.
The safety endpoints in this study will include adverse events, physical assessment, clinical laboratory assessment, selected measures of adjusted serum total calcium (Ca), serum phosphorus (P), albumin, calculated Ca x P product, and iPTH.
Joel Melnick, vice president of clinical R&D at Cytochroma, said: “SHPT is a serious condition associated with CKD and remains difficult to manage. CTA018 has the unique ability to activate vitamin D signaling pathways as well as inhibit the CYP24 catabolic enzyme. We believe that CTA018 will provide improved control of serum parathyroid hormone without the adverse impact on serum levels of calcium and phosphorus caused by existing agents.”